Toxicologist

2 weeks ago

Waltham, United States Integrated Resources, Inc ( IRI ) Full time

Primary responsibility for the Scientist/Senior Scientist in NSE is to ensure timely and high-quality deliverables from NSE to meet client's Discovery and Development goals; these deliverables include management/coordination of contracts, study-related documentation (protocols/reports), and regulatory submission documents, and program-related documents (e.g., candidate nomination). The role requires close collaboration with external contract research organizations (CROs) and client's Head ofto xicologist.

Responsibilities including but not limited to:

· Review and QC NSE study protocols, study reports, and protocol/report amendments for external studies to ensure high quality deliverables from CROs

· Review and QC NSE information in regulatory documents (e.g., prepare and/or review applicable NSE sections of IB updates, DSURs, Briefing books, INDs/BLAs)

· Review and QC NSE information in candidate nomination documents and presentation slides (e.g., prepare and/or review applicable NSE sections of IB updates, DSURs, Briefing books, INDs/BLAs)

· Process Work orders, Change orders and track invoices aProductst installment payments in contracts

· Prepare and/or review/QC NSE meeting abstracts, presentation material, as needed

· Support client's Oncology’s Head of NSE/toxicologist, as needed

Education and Experience:

BS/MS with 6-10 years of experience in biotech/pharma or CRO in a nonclinical safety assessment organization or Quality Assurance group; PhD with 0-3+ years of applicable experience

  • Must have familiarity with NSE / Toxicology Studies & related regulatory documents
  • 6-10 years of experience
  • Strong attention to detail & Written Communication skills

  • Reproductive Toxicologist

    1 month ago

    Waltham, United States AstraZeneca Full time

    **Reproductive Toxicologist - Clinical Pharmacology and Safety Sciences** AstraZeneca discovers and develops medicines in our core areas of Oncology, Respiratory and Immunology, Neuro - & Microbial Sciences and Cardiovascular, Renal and Metabolic Disease. Regulatory Toxicology & Safety Pharmacology is a global department within the Clinical Pharmacology and...

  • Toxicologist

    2 weeks ago

    Waltham, United States Integrated Resources, Inc ( IRI ) Full time

    Primary responsibility for the Scientist/Senior Scientist in NSE is to ensure timely and high-quality deliverables from NSE to meet client's Discovery and Development goals; these deliverables include management/coordination of contracts, study-related documentation (protocols/reports), and regulatory submission documents, and program-related documents...

  • Toxicologist

    2 weeks ago

    Waltham, United States Integrated Resources, Inc ( IRI ) Full time

    Primary responsibility for the Scientist/Senior Scientist in NSE is to ensure timely and high-quality deliverables from NSE to meet client's Discovery and Development goals; these deliverables include management/coordination of contracts, study-related documentation (protocols/reports), and regulatory submission documents, and program-related documents...

  • Study Monitor Toxicology

    2 days ago

    Waltham, United States AstraZeneca Full time

    Study Monitor Toxicology Introduction to Role: Join our dynamic team at AstraZeneca R&D's Regulatory Toxicology and Safety Pharmacology as a Toxicology Study Monitor. You will be instrumental in supporting the design, conduct, and reporting of non-clinical in vivo studies at Contract Research Organisations (CROs). This role is a key component in delivering...

  • Senior Scientist

    2 weeks ago

    Waltham, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Senior Scientist / Non Clinical Safety Evaluation Location: Waltham, MADuration: 6+ Months Part Time role : 20 hours per week Position Summary:Primary responsibility for the Scientist/Senior Scientist in NSE is to ensure timely and high-quality deliverables from NSE to meet Mural Oncology’s Discovery and Development goals; these deliverables include...

  • Senior Scientist

    4 weeks ago

    Waltham, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Senior Scientist / Non Clinical Safety Evaluation Location: Waltham, MADuration: 6+ Months Part Time role : 20 hours per week Position Summary:Primary responsibility for the Scientist/Senior Scientist in NSE is to ensure timely and high-quality deliverables from NSE to meet Mural Oncology’s Discovery and Development goals; these deliverables include...